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  • Is ISO 13485:2016 Quality Manual Template compliant with MDR?

    We(a U.S company) implemented and certified ISO 13485:2016 using Advisera's template package last year. I could never understand the "_EN"  at the end of the Procedure titles. We are now working with an NB to certify a class IIa product for MDR and MDSAP to sell outside the U.S. I now think I understand the " _EN". Prior to the audit our NB wants me to verify / confirm whether our Quality Manual meets the requirements of EN ISO 13485:2016 as well as MDR. Can you confirm this? The only gap I see is that Post Market Surveillance is not mentioned in the Quality Manual but I'm not sure it is a requirement for the Quality Manual.
  • Accessories to Medical Device

    We are class II manufacturers, and our device contains stimulator, its charger and charging cable. Can we call the charger and the cable as accessories or it is part of the stimulator? We don't intend to sell the charger and the cable separately except for replacement as spare parts. On the same context, we also have electrodes which is connected to the stimulator with a cable. The main intended use of the device cannot be achieved without the electrodes and cable. In this scenario can we call the elecetrodes and cable as an accessory to our device? We intend to sell the electrodes and cable each separately. I know if we are planning to sell the device separately, each need to undergo its own conformity assessment but the confusion is whether to declare it as accessory or not?  Thanks for the response.
  • ISO 13485 Certification in company without manufacturing processes

    I would like to ask you about ISO 13485 certification. Is it possible to certify a company that will outsource the production of devices? I am referring to the following business model as follows. Company A implements and certifies the ISO 13485 system and outsources all production and quality control to its subcontractor company B, which has ISO 9001. Can the company A certify itself in such a case, or if it does not have production (manufacturing) processes will the certification company not be able to carry out ISO 13485 certification audits?
  • CE mark

    For the purpose of the CE mark, our consultant prepared a post marketing surveillance (PMS) document and said that I should have (as part of the 13485) a procedure for how to prepare such a document. According to the post marketing surveillance document that our consultant prepared, I see that parts of this documents is based on procedures that are listed in different documents that you have provided (e.g., 08_Customer_Complaints_and_Feedback, 16_Adverse_Event_Investigation, and 15_Nonconformities). I wonder if you have a single document that describes the procedures for a PMS review.
  • Document control version question

    I am hoping that someone can help me with a question about document control for ISO 13485. With version control you give examples in the documentation as per below: With regards to the versions above, there is a document on version 1.2 and another on 0.6. When changes are made how are you suggesting document version is changed? Does it go from 0.0 to 0.9 and then go to 1.0? Or are minor changes illustrated by the .X number and major changes be a whole numerical shift from 0 to 1? The procedure doesn’t explain this hence me checking. And if it is the latter, how should I distinguish between a minor change and a major change?
  • 13485 Implementation

    My background in 13485 was within a manufacturing company that produced medical devices. I have now been tasked with implementing a 13485 QMS where there is no physical product. The offering facilities and services but no commercialised product. How would I tailor the 13485 standard to a facility and service when it is very strongly worded towards having a product?
  • New EU MDR - Technical File new document format

    Hello, I am working on the TF of a Class IIb device new document format to be compliant to new EU MDR regulations. I am at section Product and Design Specifications - USER REQUIREMENTS. My question is: what do they mean by User Requirements? the question is not specific enough. thank you for your quick response. Taly Bendayan
  • Acceptable or Not Acceptable

    hello quick question, Acceptable or Not Acceptable When taping an entry in a lab notebook, Is hash marks (") acceptable on the taped entry. I'm used to name and date, but I am at a new company and they use (")
  • CE Marking

    Hello, I was hoping someone could advise me on an issue with CE from a complaince perspective. A manufacturer I use has a valid CE certificate until the end of June 2022, they have told me the renewal is going thorugh, but due to new laws it is more complicated and they may not be able to obtai the renewal until the end of July. But they are sure there will be no issue. I have two questions: 1 - Bewtween the end of June and when they get the renewal, can I sell the products I hold that were manufactured under a valid CE, even though it will be out of date? 2 - If I purchase new products that have been produced without a valid CE, they will not be compliant will they? Thank you  
  • Production Part Approval Process

    I am working for a Medical Devices Company already certified to ISO 13485. Where does (PPAP) Production Part Approval Process fit in please?
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